A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients with COVID-19

INTERVENTION: Bemnifosbuvir Hemisulfate Placebo CONDITION: ; Respiratory Respiratory PRIMARY OUTCOME: The primary efficacy endpoint is the proportion of subjects in the supportive‐care‐only population who are hospitalized for any cause or who died due to any cause through Day 29. SECONDARY OUTCOME: Proportion of subjects in each population with viral load rebound (term to be defined in the SAP) through Day 29 Proportion of subjects in the overall study population, the supportive‐care‐only population, and the combination antiviral population who died due to any cause through Day 29 and Day 60 Proportion of subjects in the supportive‐care‐only population with COVID‐19‐related complications (e.g., death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis/myocarditis, cardiac failure) Proportion of subjects in the supportive‐care‐only population with COVID‐19‐related hospitalization or who died due to any cause through Day 29 Proportion of subjects in the supportive‐care‐only population with COVID‐19‐related medically attended visits (hospitalization, emergency room (ER) visit, urgent care visit, physician’s office visit, or telemedicine visit) or who died due to any cause through Day 29 and Day 60 Proportion of subjects with COVID‐19 symptom relapse (term to be defined in the SAP) in each population through Day 29 INCLUSION CRITERIA: Willing and able to provide informed consent. 2. Positive SARS‐CoV‐2 diagnostic test (RT‐PCR or validated rapid antigen test) conducted = 5 days prior to randomization. Note: The test may be obtained locally. A documented historical record of positive result (RT‐PCR or validated rapid antigen test) from test conducted = 5 days prior to randomization is acceptable. 3. Mild or moderate COVID‐19 with symptom onset = 5 days before randomization and at least one COVID‐19 related symptom present at time of screening: • Mild COVID‐19: ‐ Symptoms of mild illness with COVID‐19, which could include fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, and loss of taste or smell, without shortness of breath or dyspnea ‐ No clinical signs indicative of moderate, severe, or critical illness severity • Moderate COVID‐19: ‐ Symptoms of moderate illness with COVID‐19, which could include any symptom of mild illness or sho